Essure, approved by the Food and Drug Administration (FDA) in 2002, is a permanently implanted contraceptive device that does not require a surgical incision. It consists of two-inch long coils that are implanted in the fallopian tubes during a minimally invasive procedure. We expect Bayer to meet its postmarket obligations concerning this device.
Bayer announced Friday it would stop selling a controversial birth control implant after years of lawsuits from thousands of women alleging it caused injury and health issues. At the time of the approval, Essure was manufactured and marketed by Conceptus, Incorporated, a company Bayer acquired in June 2013.
February 2018: FDA officials met with women implanted with Essure and patient advocates to listen to their concerns and experiences with the device.
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Bayer spokesman Steven Immergut said the company had sold roughly one million Essure devices worldwide since the product came on the market in 2002.
"The benefit-risk profile of Essure has not changed, and we continue to stand behind the product's safety and efficacy, which are demonstrated by an extensive body of research", Bayer said. Based on that investigation, the FDA issued a black-box warning-the agency's most serious kind of warning-and ordered Bayer to conduct a post-market study to evaluate the safety of Essure. In a statement released by the Agency, FDA Commissioner Scott Gottlieb, MD, said "I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who've already had this device implanted".
The Food and Drug Administration said earlier this year that over a 15-year period - November 2, 2002, when Essure was approved, through December 2017 - the agency received more than 26,000 reports of problems, including pain, heavier periods and irregular bleeding, headaches and fatigue. We'll continue to monitor adverse events reported to our database, as well as other data sources. They also claim that the device failed to prevent unwanted pregnancies and led to nickel allergies and depression. Our Medical Device Safety Action Plan, issued in April, captures numerous efforts that we're undertaking.
On Tuesday, Firmalino and other Essure activists held a daylong protest outside Bayer's us headquarters in Whippany, N.J. As part of it, they broadcast a clip from the forthcoming Netflix documentary about medical device failures called The Bleeding Edge.